NCT01040585

Brief Summary

The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

December 24, 2009

Last Update Submit

March 1, 2012

Conditions

Ventilator Acquired Pneumonia

Keywords

cost effectivenesslinezolidventilator acquired pneumoniacentral america

Outcome Measures

Primary Outcomes (4)

  • The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin.

    4 months

  • Rate of renal failure.

    4 months

  • Rate of healing with Linezolid.

    4 months

  • Rate of healing with Vancomycin.

    4 months

Secondary Outcomes (3)

  • Hospitalization days average with VAN and Linezolid.

    4 months

  • Variation of prices and values among the different institutions.

    4 months

  • The average costs of each intervention.

    4 months

Study Arms (1)

Central America and the Caribbean

Panama, Costa Rica, Honduras, El Salvador and Nicaragua

Drug: Linezolid

Interventions

LinezolidDRUG

Treatment for VAP as indication approved and as physician criterium.

Central America and the Caribbean

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult men and women with VAP.

You may qualify if:

  • Evidence of a legally acceptable representative signed and dated informed consent document indicating that him or her has been informed of all pertinent aspects of the study.
  • Adult (18 years old or older) men and women with confirm diagnosis of VAP treated on ICU with LIN or VAN; on the selected institutions.

You may not qualify if:

  • Adult men or women with nosocomial pneumonia not associated to a ventilator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 29, 2009

Study Start

July 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 2, 2012

Record last verified: 2012-03